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Twelve months prevention of heartworm (Dirofilaria immitis) disease in dogs, and control of larval and adult infections of canine hookworms (Ancylostoma caninum and Uncinaria stenocephala) at the time of treatment.

Contraindications

Injection of suspended product intravenously.

Precautions

Use aseptic technique at all times. Proheart SR-12 Injection may be administered to dogs treated with Revolution (selamectin). A safety study showed that administration of Proheart SR-12 Injection to 12 week old puppies treated with Revolution was safe. However, the safety of concurrent treatment with Revolution and Proheart SR-12 Injection has not been demonstrated in macrocyclic lactone sensitive breeds, e.g. sensitive collies.First Aid If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131 126.Disposal Dispose of empty container by wrapping with paper and putting in garbage. Discarded needles should immediately be placed in a designated and appropriately labelled sharps container.

Dosage and Administration

Mixing directions. Use only the ProHeart SR-12 Injection sterile vehicle provided in this pack. Do not substitute with other solutions of any type. Using the sterile 18 gauge x 1 inch needle and the sterile syringe provided, withdraw 8 mL (small pack), or 40 mL (large pack), of sterile vehicle from the vial labelled ProHeart SR-12 Injection Sterile Vehicle. (There is more than the required 8 or 40 mL of vehicle supplied in the vial.) Insert the 25 gauge x ½ inch vent needle provided in the package into the vial labelled ProHeart SR-12 Injection Microspheres to act as a vent. Transfer the sterile vehicle into the microsphere vial using the transfer needle and syringe. Once the sterile vehicle has been added, remove the vent and transfer needles from the microsphere vial. Discard unused vehicle and needles (see disposal directions below). Do not leave the vent needle in the bottle after suspending. Shake the microsphere vial thoroughly until an evenly mixed suspension is produced (for approximately 30 seconds). Allow the suspension to stand for at least ten minutes (preferably 30 minutes) to allow large air bubbles to dissipate. Record the date of mixing on the microsphere vial. Before every use, gently swirl the mixture to achieve a uniform suspension. The microspheres and sterile vehicle will gradually separate and sediment out on standing. Use an appropriately sized sterile syringe with an 18 or 20 gauge x 1 inch needle for administration. A 20 gauge needle is recommended for dogs less than 20 kg, and an 18 gauge for those over 20 kg. Administer promptly after filling the syringe. If administration is delayed, gently rock the syringe prior to injection to maintain an even suspension of microspheres and ensure accurate dosing. Store unused product under aseptic conditions at 2 to 8°C.Administration. Recommended for use in dogs from 12 weeks of age. Administer 1 mL of suspension/20 kg bodyweight subcutaneously to provide a dose of moxidectin 0.5 mg/kg bodyweight. Rock the syringe to maintain the suspension and inject subcutaneously under the loose skin on the dorsum or the side of the neck, anterior to the scapula. To maintain full protection in adult dogs, repeat the treatment every twelve months.Dosage guide. Dogs 1 kg bodyweight: 0.05 mL; 5 kg: 0.25 mL; 10 kg: 0.5 mL; 15 kg: 0.75 mL; 20 kg: 1 mL; 25 kg: 1.25 mL; 30 kg: 1.5 mL; 35 kg: 1.75 mL; 40 kg: 2 mL; 45 kg: 2.25 mL; 50 kg: 2.5 mL; 55 kg: 2.75 mL; 60 kg: 3 mL; 65 kg: 3.25 mL. Dogs over 65 kg receive 0.25 mL for each additional 5 kg bodyweight.General directions. Pharmacological considerations. The following features of the pharmacology of ProHeart SR-12 Injection should be taken into consideration when designing a heartworm prevention program to suit individual dogs. In adult dogs (over 9 months of age) of all types, ProHeart SR-12 Injection will provide at least 12 months protection against heartworm disease. In growing puppies the dilution effect of increasing body mass may affect the duration of protection of the recommended dose of ProHeart SR-12: the recommended dose will protect puppies of all breeds of 3 to 6 months of age for at least 6 months, and puppies of 6 to 9 months of age for at least 9 months. Dogs or puppies may be safely retreated with ProHeart SR-12 Injection at the recommended dose rate at less than the intervals indicated above to synchronise with other routine procedures. The retrospective activity (reach back effect) of ProHeart SR-12 Injection will kill the immature larval stages of Dirofilaria immitis resulting from infections acquired within the three months preceding the administration of a recommended dose. The following recommended programs are a guide only and may be appropriately adapted by the veterinarian to suit individual cases or clinic protocols. Puppies. Puppies will ideally receive their first treatment with ProHeart SR-12 Injection at 3 months of age. This will give them at least six months' protection against heartworm disease, and also inactivate any heartworm infection acquired since birth. This administration can be timed to coincide with the 3 month vaccination. Use a dose rate based on the dog's bodyweight at the time of treatment (i.e. do not overdose in anticipation of the puppy's expected future weight). Re-treatment or (if treatment at 3 months of age was missed) initial treatment may be carried out at 6 months of age (or at a time close to that) to coincide with admission for neutering. This will give at least nine months' further protection enabling the next treatment to be administered at 15 months of age to coincide with an annual health check or revaccination. Note that if initial treatment is administered after 3 months of age, heartworm infections acquired more than three months previously may not be fully controlled. After 15 months of age, annual re-treatment should be administered as described for adult dogs below. Adult dogs. Dogs over 9 months of age may be started on a ProHeart SR-12 Injection program at any time in accordance with the following guidelines. A complete heartworm disease prevention program includes a periodic physical examination and a test for the presence of adult heartworm. All dogs not currently on a heartworm prevention program should be tested for the presence of adult heartworms. While ProHeart SR-12 Injection is safe in heartworm positive dogs, it should only be used in dogs testing negative for circulating microfilariae or adult heartworm antigen. Infected dogs should be treated to remove adult heartworms and microfilariae before initiating treatment with ProHeart SR-12 Injection.If ProHeart SR-12 Injection is replacing a monthly heartworm preventive medication, the first administration of ProHeart SR-12 Injection should be given within one month of the last treatment; however, because of its retrospective activity, ProHeart SR-12 Injection is efficacious against heartworm infection acquired within the three months prior to administration. Therefore, there is continuity of coverage if given within 90 days of the previous treatment. If more than 90 days have elapsed since the previous treatment, ProHeart SR-12 Injection can be administered, but it is recommended that the dog be tested for the presence of adult heartworm six months later and treatment instituted if necessary. Dogs on daily heartworm prevention may commence treatment with ProHeart SR-12 Injection at any time. Annual re-treatment. A repeat annual dose of ProHeart SR-12 Injection should ideally be given on the anniversary of the dog's previous treatment with the product. However, because of its retrospective activity, ProHeart SR-12 Injection is efficacious against heartworm infection acquired within the three months prior to administration, so there is continuity of coverage if re-treatment is given within 90 days of the anniversary of the previous treatment. If more than 90 days have elapsed since the anniversary of the previous treatment, ProHeart SR-12 can be administered, but it is recommended that the dog be tested for the presence of adult heartworm six months later and treatment instituted if necessary. Other directions. ProHeart SR-12 Injection may be administered simultaneously with vaccines or other medications, but injections must be made at a separate site and other medications must not be mixed in the syringe with ProHeart SR-12 Injection.Proheart SR-12 injection may be administered to dogs treated with Revolution (selamectin). Clinical studies in puppies being treated with Revolution have shown that the administration of Proheart SR12 is safe from 12 weeks of age.ProHeart SR-12 Injection may be used in breeding dogs of either sex at any stage of the reproductive cycle and in lactating bitches.ProHeart SR-12 Injection may safely be used as directed in ivermectin sensitive collies. ProHeart SR-12 Injection may safely be administered as directed in heartworm positive dogs, although prior testing to determine the dog's status is advisable, as ProHeart SR-12 Injection will not remove a pre-existing adult infection.Control of canine hookworms (A. caninum and U. stenocephala) is at the time of treatment only. For ongoing control use other treatment as appropriate.

Storage

Before suspending, store below 30°C (room temperature). Product suspended for injection as directed may be stored for up to eight weeks between 2 and 8°C. (Refrigerate. Do not freeze).